This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD) while monitored at home with the ForeseeHome Monitoring System (FSH) and during routine care with Spectral Domain Optical Coherence Tomography (SD-OCT) and to validate the predictive value of a non-NV-AMD FSH alerts.

开始日期2022-12-15

申办/合作机构

Notal Vision, Inc.

NCT05745116 / RecruitingN/A

Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision

Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites.

开始日期2022-11-07

申办/合作机构

Notal Vision, Inc.

NCT05650047 / RecruitingN/A

Home OCT Guided Management Study of Subjects Diagnosed With Neovascular-AMD

During the last 25 years, OCT has become one of the most common imaging technologies used to diagnose and monitor retinal diseases, including AMD. The OCT self-imaging capabilities of the Notal Vision Home OCT (NVHO) system for retinal fluid visualization in the central 10 degrees were validated during several prospective clinical studies1,2,3,4,5. This study is designed to evaluate the retinal fluid exposure of eyes with NV-AMD, using the NVHO system to guide therapy.

开始日期2022-09-09

申办/合作机构

Notal Vision, Inc.

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2020-12-01·Klinische Monatsblätter für Augenheilkunde4区 · 医学

Evaluation of a Self-Imaging SD-OCT System for Remote Monitoring of Patients with Neovascular Age Related Macular Degeneration

4区 · 医学

Article

作者: Loewenstein, Anat ; Benyamini, Gideon ; Nahen, Kester

Abstract Background The treatment of patients with neovascular age-related macular degeneration (nAMD) requires frequent office visits to identify fluid in the retina that requires treatment. Frequent office-based examinations using optical coherence tomography (OCT) are a burden on patients and their care givers. The development of OCT systems that can be self-operated by patients at home offers the potential for precise remote monitoring and improved individualized therapy. Patients/Material and Methods An investigational spectral domain OCT system (Notal Vision Home OCT, NVHO) for automatic patient-guided self-imaging intended for commercialization was evaluated in a total of 69 study participants with neovascular age-related macular degeneration with regard to image quality and usability. An artificial intelligence-based algorithm was used to identify, quantify and map intra- and subretinal fluids. Results Successful imaging with the NHVO was performed in all patients and in 93% of the enrolled eyes. The positive percent agreement and negative percent agreement for detection of fluid, intraretinal fluid, and subretinal fluid in at least one of three consecutive NHVO images was 97/95%, 96/94% and 100/98%, respectively, when compared to commercial in-office OCT systems. In 1.4% of the recorded eyes, fluid was only detected outside of the central 10 × 10° field of view but seen on a commercial OCT system with a larger field of view. The device operation for scanning their own eyes without assistance was rated by 95% of patients as easy. The analysis and depiction of fluid distribution and volume in a longitudinal case study illustrated the acute nature and anti-VEGF therapy response of nAMD. Conclusion The evaluated OCT system for home use meets the requirements for self-controlled imaging by nAMD patients with regard to image quality, field of view and usability. Image analysis based on artificial intelligence can potentially support clinicians in the assessment and utilization of large amounts of data generated by daily home OCT imaging.

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